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鹿药的质量标准研究
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| 篇名： | 鹿药的质量标准研究 |
| TITLE： | |
| 摘要： | 目的：建立鹿药的质量标准。方法：从原植物形态、性状特征、显微特征、薄层色谱（TLC）等方面对药材进行定性鉴别；测定药材的水分、灰分、浸出物；采用高效液相色谱法测定药材中（25S）-17α-羟基-5α-螺甾烷-9-烯-3β-O-β-D-葡萄吡喃糖基-（1→2）-[β-D-木吡喃糖基（1→3）]-β-D-葡萄吡喃糖基（1→4）-β-D-半乳吡喃糖苷（SJ-13）的含量，色谱柱为Waters SunFire C18，流动相为乙腈-水（35 ∶ 65，V/V），流速为1.0 mL/min，检测波长为203 nm，柱温为20 ℃，进样量为10 μL。结果：原植物为多年生草本植物，高30～60 cm；药材表面呈棕色至棕褐色，具皱纹；显微特征为表皮1列细胞；药材粉末呈灰黄色，含大量草酸钙针晶。药材样品的TLC图斑点大部分清晰，分离度好；药材中水分为5.26％～8.88％，总灰分为4.60％～28.86％，酸不溶性灰分为1.56％～23.39％，水浸出物为23.84％～51.26％，醇浸出物为22.65％～57.36％；SJ-13检测进样量线性范围为8.92～31.22 μg（r＝0.999 9），精密度、稳定性、重复性试验的RSD均小于1％，加样回收率为97.0％～99.2％（RSD＝0.8％，n＝6），耐用性试验的RSD均小于1％，10批药材样品中SJ-13的含量范围为4.40～29.80 mg/g。结论：初步拟定鹿药药材中水分不得过11％，总灰分不得过35％，酸不溶性灰分不得过28％，水浸出物不得少于19％，醇浸出物不得少于18％，SJ-13含量不得少于4.40 mg/g；该试验所建标准可用于鹿药的质量控制。 |
| ABSTRACT： | OBJECTIVE： To establish the quality standard of Smilacina japonica. METHODS： S. japonica was identified qualitatively in respects of original plant morphology， character， microscopic identification， TLC， etc. The moisture， ash and extract of medicinal materials were determined. The content of （25S）-17α-hydroxy-5α-spirostane-9-ene-3β-O-β-D-glucopyranoyl-（1→2）-[β-D-xylanosyl（1→3）]-β-D-glucopyranoyl（1→4）-β-D-galactopyranoside（SJ-13） was determined by HPLC. The determination was performed on Waters SunFire C18 column with mobile phase consisted of acetonitrile-water（35 ∶ 65，V/V） at the flow rate of 1.0 mL/min. The detection wavelength was set at 203 nm and the column temperature was 20 ℃. The sample size was 10 μL. RESULTS： The original plant was perennial herbal， with height of 30-60 cm. The surface of the medicinal material was brown to brownish brown， with wrinkle and 1 row cells in epidermis. The powder of medicinal material was grayish yellow and contained large amount of acicular crystal. TLC spots were clear and well-separated. The content of moisture was 5.26％-8.88％； the content of total ash was 4.60％-28.86％； the acid-insoluble ash was 1.56％-23.39％， water extract was 23.84％-51.26％ and alcohol extract was 22.65％-57.36％. The linear range of SJ-13 were 8.92-31.22 μg（r＝0.999 9）. RSDs of precision， stability and reproducibility tests were all lower than 1％. The average recoveries were 97.0％-99.2％（RSD＝0.8％，n＝6）. RSD of durability test was lower than 1％. The content of SJ-13 was 4.40-29.80 mg/g in 10 batches of medicinal samples. CONCLUSIONS： The content of water， total ash， acid insoluble components should not exceed 11％， 35％， 28％； the content of water extract， alcohol extract and SJ-13 should not be less than 19％， 18％ and 4.40 mg/g， respectively. Established standard can be used for the quality control of S. japonica. |
| 期刊： | 2018年第29卷第20期 |
| 作者： | 崔誉文，刘银环，热萨莱提·图尔孙，毛昭琦，宋小妹 |
| AUTHORS： | CUI Yuwen，LIU Yinhuan，Resalaiti·TUERSUN，MAO Zhaoqi，SONG Xiaomei |
| 关键字： | 鹿药；质量标准；显微特征；薄层色谱法；含量测定；高效液相色谱法 |
| KEYWORDS： | Smilacina japonica； Quality standard； Microscopic identification； TLC； Content determination； HPLC |
| 阅读数： | 498 次 |
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